Regulation (EU) 2017/746 (IVDR) — key articles
The full text of IVDR 2017/746 is available in the Official Journal: OJ L 117, 5.5.2017, p. 176–332. All article references on this site refer to the IVDR as amended, including Regulation (EU) 2022/112 and Regulation (EU) 2024/1860.
This site provides article summaries for navigation purposes only. Always refer to the official consolidated text for legal compliance purposes.
Structure of the IVDR
IVDR 2017/746 contains 113 Articles and 16 Annexes, mirroring the MDR structure closely. Key differences from MDR reflect the in vitro diagnostic context.
| Chapter | Articles | Subject |
|---|---|---|
| I | 1–4 | Scope, definitions, regulatory status |
| II | 5–10 | Placing on market; economic operator obligations |
| III | 11–15 | Identification, traceability, registration |
| IV | 16–20 | Notified bodies |
| V | 21–35 | Classification and conformity assessment |
| VI | 36–52 | Performance evaluation and performance studies |
| VII | 53–60 | Market surveillance and vigilance |
| VIII | 61–75 | Cooperation; MDCG |
| IX | 76–97 | Confidentiality, funding, penalties |
| X | 98–113 | Final provisions; transitional |
Key IVDR articles — by theme
Scope and definitions
Art. 1 — Scope: IVDs, accessories, and software. Excludes products for veterinary use, general laboratory equipment, and products for research use only not placed on the market for diagnostic purposes.
Art. 2 — Definitions: 69 definitions. Critically differs from MDR in:
- Art. 2(2): IVD definition (in vitro, human specimens)
- Art. 2(4): Near-patient testing
- Art. 2(5): Self-test
- Art. 2(7): Companion diagnostic
- Art. 2(67): Serious incident (IVD-adapted)
Economic operators (parallel to MDR, with IVD adaptations)
Art. 7 — Claims: Same prohibition structure as MDR Art. 7 — no misleading, false, or unsubstantiated claims.
Art. 10 — Manufacturer obligations: Full QMS, technical documentation, conformity assessment, CE marking, PMS, vigilance, EUDAMED registration — all required.
Art. 16 — EU REP obligations: Same structure as MDR Art. 11.
IVD-specific articles
Art. 47 — Classification: IVDR's four-class system (A, B, C, D). Commission power to reclassify.
Art. 48 — Conformity assessment:
- Class A (non-sterile): self-declaration
- Class A (sterile): partial NB involvement
- Class B, C: Annex IX or Annex X + XI
- Class D: Annex IX only + EU reference laboratory review
Art. 48(3) — Companion diagnostic consultation: Before issuing a certificate for a companion diagnostic, the NB must seek a scientific opinion from EMA or a national medicines authority.
Art. 56 — Performance evaluation: The IVDR equivalent of MDR Art. 61. Requires a systematic, proactive, and planned process throughout the IVD lifecycle. Includes analytical performance, clinical performance, and scientific validity.
Art. 57–77 — Performance studies: The IVDR equivalent of MDR clinical investigations. Framework for interventional and non-interventional performance studies.
Art. 78–81 — PMS system: PMS system, PMS plan, PSUR (Class C and D), PMS report (Class A and B), and PMPF.
Art. 82–87 — Vigilance: Serious incident reporting (adapted for IVD context — including false results leading to patient harm); FSCAs; trend reporting.
Art. 100 — EU reference laboratories (EURLs): Designation and role of EURLs in Class D IVD conformity assessment; batch testing verification.
Transitional provisions
Art. 110 — Transitional provisions: Continued validity of IVDD certificates; conditions for continued marketing. As amended by:
- Regulation (EU) 2022/112 — first extension of IVDR transitional dates
- Regulation (EU) 2024/1860 — further extensions (Class D to Dec 2027; Class C to Dec 2028; Class B to Dec 2029; Class A self-declared to Dec 2030)
The 16 IVDR Annexes
| Annex | Content |
|---|---|
| I | General Safety and Performance Requirements (GSPR) |
| II | Technical documentation |
| III | Technical documentation on post-market surveillance |
| IV | EU Declaration of Conformity |
| V | CE marking |
| VI | Information to be submitted upon registration |
| VII | Requirements for notified bodies |
| VIII | Classification rules (Rules 1–7) |
| IX | Conformity assessment based on QMS |
| X | EU type examination |
| XI | Product conformity verification |
| XII | Certificates issued by notified bodies |
| XIII | Performance evaluation and PMPF |
| XIV | Performance studies |
| XV | Correlation table (IVDD to IVDR) |
| XVI | (Reserved) |
MDR vs. IVDR — key structural parallels
| MDR | IVDR | Topic |
|---|---|---|
| Art. 61 | Art. 56 | Clinical / performance evaluation |
| Art. 62–82 | Art. 57–77 | Clinical investigations / performance studies |
| Art. 83–86 | Art. 78–81 | PMS system |
| Art. 87–92 | Art. 82–87 | Vigilance |
| Annex XIV | Annex XIII | CER/CIP equivalent (PMCF / PMPF) |
| Annex XV | Annex XIV | Clinical investigations / performance studies |
| Art. 120 | Art. 110 | Transitional provisions |
Related pages
- MDR key articles
- IVDR Annexes
- Classification — Class A · B · C · D
- Performance evaluation
- EU reference laboratories
Official references
| Reference | Description |
|---|---|
| OJ L 117, 5.5.2017, p. 176 | IVDR original publication |
| Regulation (EU) 2022/112 | First IVDR transitional amendment |
| Regulation (EU) 2024/1860 | Further IVDR transitional amendments |
| EUR-Lex consolidated text | Current consolidated IVDR |